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PDUFA date. In United States pharmaceutical regulatory practice, the PDUFA date is the colloquial name for the date by which the Food and Drug Administration must respond to a New Drug Application or a Biologics License Application. [1] It is part of the regime established by the Prescription Drug User Fee Act to ensure funding of the Food and ...
Alpidem (Ananxyl) 1995. Worldwide. Not approved in the US, withdrawn in France in 1994 [ 4] and the rest of the market in 1995 because of rare but serious hepatotoxicity. [ 3][ 5] Alosetron (Lotronex) 2000. US. Serious gastrointestinal adverse events; ischemic colitis; severe constipation. [ 2] Reintroduced 2002 with restricted indication and ...
Regulatory decisions made by the Food and Drug Administration (FDA) often serve as important catalysts for pharmaceutical stocks. In the following video, health-care analyst Max Macaluso discusses ...
As of the end of 2013, the FDA and its predecessors had approved 1,452 drugs, though not all are still available, and some have been withdrawn for safety reasons. Accounting for subsequent corporate acquisitions, these approvals were earned by approximately 100 different organizations.
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Bad news: The 27 new drugs approved this year is a far cry from 2012's banner year for approvals, in which the Food and Drug Administration signed off on 39 drugs. Good news: While the quantity ...
The United States Food and Drug Administration (FDA) initiated the FDA Accelerated Approval Program in 1992 to allow faster approval of drugs for serious conditions that fill an unmet medical need. The faster approval relies on use of surrogate endpoints. [1] Drug approval typically requires clinical trials with endpoints that demonstrate a ...
The Food and Drug Administration ensures that the benefits of newly approved drugs outweigh their potential side-effects. However, it's not always easy to predict which way the FDA will decide ...